Protective device

ABSTRACT

A device for protecting body portions which are exposed to large amounts of the radiation from the sun. The device is molded into the shape of the body portion from a material which is formretaining, tear-resistant, soft, flexible and lightweight. An adhesive is provided on the inner surfaces of the device. The device is ventilated by through-pores or by the manner in which the adhesive is distributed on the inner surfaces.

United States Patent 1.436313 11/1922 Hafer 2/206 1.761.664 6/1930 Harris 2/206 2.928.388 3/1960 .laroslawt 2/2 X 3,068.863 12/1962 Bowman 1 128/132 3.300786 10/1967 Resenvold et a1 2/2 3.452.365 7/1969 Wallace i 2/209 FOREIGN PATENTS 1.021,758 12/1952 France 2/9 Primary Examiner-H. Hampton Hunter Anomey Fowler, Knobbe and Martens ABSTRACT: A device for protecting body portions which are exposed to large amounts of the radiation from the sun. The

device is molded into the shape of the body portion from a material which is form-retaining, tear-resistant, soft, flexible and lightweight. An adhesive is provided on the inner surfaces of the device. The device is ventilated by through-pores or by the manner in which the adhesive is distributed on the inner surfaces.

PATENTED Jum I97! SHEET 1 [1F 2 I INVENTOR. E0663 5'. .S'ANDEESO/V UWL EB, [N0856- 4 T mews/s.

PATENTEU .1112? 871 35941813 SHEET 2 OF 2 INVENTOR. 066? .52 SANDEZSO/V harmful rays of the sun are therethrough.

' PROTECTIVE nEvlcE BACKGROUND or lNVENTlON it is known that excessive exposure of the human body to ultraviolet radiation can cause severe damage to the tissue of the exposed body portions and may aggravate the tissues to a sufficient degree to cause carcinomas thereon. Severe carcinomas on the ears, nose, lips, or soft eye tissue may, require complete removal of the tissue to prevent spreading of the cancerous growth. The factor which is often associated with the cause of these cancerous growths is overexposure to the burning ultraviolet rays of the sun.

A person who spends a great deal of time in the sun such as a construction worker, sailor, surfer, swimmer or lifequard may receive overdosages of the sun's radiation on the ears or nose if care is not taken to protect these body portions. While the initial result of overexposure may be a severe burn of the skin tissue, repeated exposure with continued irritation of the tissue ultimately may result in the formation of a carcinoma. For example, one hospital in Southern California over the last years has recorded several hundred cases of cancer of the nose, lips and ears and in most of the cases the patient was of the caucasian race and had spent many hours in the sun due to the nature of his occupation or by preference. In a review of the case histories of 150 patients with skin cancer of the nose (see Arch Otolaryng, Vol. 84, July, 1966) irradiation was found to be an etiologic factor in more than half of the patients. The significance of ultraviolet rays as a fundamental cause of skin cancer is further discussed in H. F. Blums book Carcinogenesis by Ultraviolet Light Press, I959).

Although devices have been suggested in the past for shading the exposed body portions from the sun, such as the nose protector shown in US. Pat. No; l,76l,664, none of these devices have been entirely satisfactory for several reasons. For example, the nose protector shown in the mentioned patent is formed from a hard celluloid material which clamps about the lower sides of the nostrils. Such a device cannot be conveniently worn if the wearer is active since it may slip off. Additionally, it cannot be worn in the water because there is nothing for holding it in place if the water brushed against the hard celluloid. Also, such devices cannot be conveniently carried about in a purse,beach bag or pocket without cracking of the hard celluloid. The device also isrelatively unattractive and readily noticeable.

Although the device may act as a shield for the tissue over which it is worn, it also may reflect ultraviolet radiation on to the surrounding facial tissue and intensify the radiation effects in these areas. 1

Thus to shield exposed body portions from the harmful rays of the sun, a device should beavailable which is formflt'ting can be made attractive, can be reused and can be worn in the water by a surfer or swimmer as well as on the beach. The device should also be readily formable so that it fits closely to the wearers ears, lips, nose or other exposed body portions without discomfort. Additionally, such a device,must include a means for ventilating the exposed body portion so the perspiration and air circulation can still be maintained while the prevented form penetrating (Princeton University SUMMARY OF INVENTION This invention is directed toward. a molded protective device for fitting over an exposed body portion and shielding the exposed portion from the rays of the sun. The device comprises a reusable, soft, resilient, flexible, thin-walled molded member which may be form fitted for placing over the exwhich are a suspension of finely divided vinyl chloride polymer (such as Geon l2l dispersion resin) or copolymer in a liquid plasticizer with sufficient filler to produce the desired resiliency, or acrylics such as the pure acrylic polymer emulsion gel Gel medium" produced by Liquitex, or mixtures of these materials or other materials having similar properties.

The adhesive that has been found to be most satisfactory for use with the protective devices of this invention is a polysiloxane pressure sensitive adhesive known as medical adhesive B produced by Dow Corning of Midland, Mich. The adhesive may be purchased as an aerosol spray having the polymer dissolved in a fluorocarbon propellant. Any other adhesive material which provides a water resistant adhesion between skin tissue and the device can be used, however, such as the two-sided adhesive tapes conventionally available; For the initial few wearings, the adhesive nature of the molded resin may be sufficient to maintain the device in place so that an additional adhesive means may not have to be applied.

Proper ventilation through the protective device for the exposed body portion may be provided by perforating the protective device with a sharp instrument such as a dental pick or other such sharp pointed instrument. Another manner of providing perforations through the device is to provide a mold which has a body portion defining cavity in which both the top and bottom sections are joined by several thin connecting portions which automatically perforate the devices molded therein. In lieu of perforations through the device the adhesive can be applied so that the fit is not airtight about all portions of the prosthesis.

One feature of the device of this invention is that it retains its shape and cannot be easily mutilated or torn during no'nuse.

Another feature of the device of this invention is that it provides complete shielding of the harmful rays of the sun from exposed body portions with a minimum amount of discomfort and inconvenience in use.

Still another feature of the device of this invention is that it can be worn in the water without danger of losing the device or harming it.

Still another feature of the device of this invention is that it is economical to produce and can be'custom fitted to the individual user or fitted in general sizes which accommodate a mers and surfers in a manner which might ultimately result in sufficient irritation to cause cancer of these body portions.

Yet another feature of this invention is that the devices are completely washable so that a new, fresh appearance is always maintained and lightweight so that they do not become uncomfortable after long periods of wearing.

Another feature is that the features of the body portion being protected or other ornamental or useful designs can be painted on the devices.

Another feature of the device of this invention is that it is noncracking and will not wash off so that it doesnt have to be reapplied after contact with water.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. I is a rear side perspective view of a nasal protective device constructed in accordance with this invention;

FIG. 2 is a representative view ofa device constructed in accordance with this invention as worn by an individual;

FIG. 3 shows a molding cup containing a hardenable material for use in the process of forming the protective devices of this invention;

FIG. 4 is a somewhat diagrammatic partially sectional view illustrating the manner in which the molding cup of FIG. 3 is used;

FIG. 5 is a sectional view through a full cup containing the hardened impression material from the molding cup of FIG. 4 and a plaster layer in the upper portion thereof;

FIG. 6 illustrates a hardened plaster mold formed as shown in FIG. 5;

FIG. 7 illustrates a thin layer of molding wax forming a pattern over the plastic cast ofFIG. 5;

FIG. 8 is a sectional view through a molding flask which contains hardenable plaster over the wax pattern and plaster mold of FIG. 7;

FIG. 9 illustrates the addition of a moldable resin to the molded shape of FIG. 5;

FIG. 10 is a sectional view through the molding flask with the molding resin therein;

FIG. 11 illustrates the manner in which a spray adhesive may be applied to the inner surfaces of the protective device ofthis invention; and

FIG. 12 illustrates a device constructed in accordance with an alternative embodiment ofthis invention.

DESCRIPTION OF PREFERRED EMBODIMENT FIG. 1 illustrates a resilient, soft, pliable, molded protective device produced in accordance with this invention for use as a nasal protector. As discussed, various exposed body portions such as the ears, lips, fingers, etc., can be shielded from excessive ultraviolet radiation from the sun by forming such a protective device. The device shown in FIG. I comprises a molded, thin, resilient, nose-shape-retaining shell I0 having a plurality of through-perforations 12 therein. It has been found sufficient to have three perforations 12 through each side of the shell 10. These perforations permit ventilation of the nose over which the device is worn but are too small in diameter in relationship to the thickness of the shell 10 to permit substan tial amounts of sun rays to pass therethrough. Consequently, the device when worn is comfortable, cool, and permits ventilation while at the same time it prevents any damage from the rays of the sun.

The inner surfaces 14 of the shell 10, which contact the sensitive skin tissue of the wearer's nose, may be coated with an adhesive material 16 such as the polysiloxane pressure sensitive adhesive polymers. This material can be conveniently purchased in aerosol spray form and is both water resistant reusable. The adhesive can either by applied immediately after the device is molded or may be purchased separately by the user and applied prior to wearing and whenever it is needed thereafter.

The device itself may be formed form a moldable resin which can be either cured at room temperature or at an elevated temperature. The main requirements for the molding material are that it be form-retaining resilient, pliable and tear resistant so that it can be reused over long periods of time without damage. The preferred molding material is a silicone resin which after 24 hours curing at room temperature has a durometer hardness of about 50 (Shore A"), a tensile strength of about 525 p.s.i., a tear strength of about 29 p.s.i. and elongation of about 230 percent. Such a material is marketed under the trademark Silastic" 399 Prosthetic Elastomer. Any materials having these and comparable properties along with the necessary form retention and pliability are usable; however. For example acrylic resins and vinyl resins, as mentioned, may also be used. A coloring agent such as acrylic paint pigments may be added to make the device flesh colored or any other desired color. These coloring media and others which can be used are disclosed in the chapter on Polymer Tempera in the book Synthetic Painting Media" by L. N. Jensen, Prentice Hall, Inc., I964, which is hereby incorporated by reference.

Referring now to FIG. 2, it will be seen that the device of this invention is substantially formfitting so that it can be worn conveniently and comfortably without appearing unattractive. A pair of nostril orifices 18 are formed in the lower edge of the device to permit freedom of breathing and comfort in wearing. As shown in FIG. 2, it can be form fitted about the nose so that its appearance is less readily noticeable than the zinc oxide type sun burn creams that are used by life guards and others who are in the sun for long periods of time.

Although the device of this invention may be adapted to protect body portions other than the nose, as previously discussed, for purposes of illustration the manner of forming the device of this invention will be discussed with particular emphasis on the process for forming a nasal protective device.

As shown in FIG. 3, a molding cup 20 containing an impressionable material 22 such as sodium or calcium algenate which is originally a powder is provided for the prospective user of the device. By mixing the algenate powder with water, an impressionable material which hardens in a short period of time is formed. The cup shown in FIG. 3 preferably has its upper edge 23 curved to conform to the facial curvature of an individual. The molding cup 20 may be a conventional polystyrene drinking cup which has the upper part removed to form the curved edge 23.

After the algenate powder 22 is mixed with water to form the impressionable material, the molding cup 20 may be placed over the body portion to be molded e.g. the nose as shown in FIG. 4 to form a pattern impression. The algenate 22 readily conforms to the facial features of the user as shown in FIG. 4. As soon as the pattern impression 24 is formed in the algenate, the cup may be removed and the algenate allowed to harden. In this manner a hardened true impression of the nose ofthe user is provided for use as a pattern in forming the mold.

The next step of the process of this invention, as shown in FIG. 5, is to transfer the hardened algenate pattern 24 from the molding cup 20 into a full cup 26 which may be conveniently a plastic drinking cup. A hardenable molding plaster 29 is then poured into the cup over the algenate pattern 24 and the plaster is permitted to sit and harden for a period of about 15 minutes or more. After the plaster has hardened, the algenate is removed and a plaster molded nose 30 surrounded by a plaster base 32 such as shown in FIG. 6 results. This forms a part of the lower half or drag portion of the mold. The plaster mold of FIG. 6, since it is formed from the impression 24 in the algenate 22, is an accurate reproduction of the surface ofthe nose of the individual.

In the next step, a thin layer of ordinary molding or baseplate wax 34 is heated to a soft pliable condition and worked over the plaster mold nose 30 to form a wax pattern of the nose. The excess wax is cut away from all portions except the nose 30 as shown in FIG. 7. This wax may then be perforated by a stylus or other sharp instrument to form a plurality of small pores 36 in the wax. Three small diameter pores on each side of the nose are preferred.

After the wax has hardened about the nose 30, the mold of FIG. 7 is placed into the drag half 38 of a casting flask 40. When the mold of FIG. 7 is placed in the drag it may be necessary to add wet plaster as a till about the mold base 32. This depends, of course, on the size of the flask used.

After the drag has been prepared, the top half of the flask or cope" 42 is placed over the drag 38 and filled with an upper layer of plaster 44 of other hardenable material. This plaster 44 passes through the perforation 36 in the wax to form a pluplaster base 32 before the upper layer of plaster 44 is poured thereon to facilitate separation of the cope and drag portions after the hardening of the plaster. The plaster for both the cope and drag portions of the mold may be Plaster of Paris or a mixture of Plaster of Paris and stone. The wax pattern 34 may be coated with a debubblizer prior to pouring the plaster 44.

After the cope 42 plaster 44 has hardened heat is applied to the flask of FIG. 8 in sufficient quantity to melt the wax and remove it forming a mold cavity 47 above the nose mold 30. This provides a casting mold having a thin cavity therein which is in the shape of the nose of the individual of FIG. 2 and which has tiny pinlike plaster extensions 48 protruding downwardly from the cope into the drag. Heating of the flask for melting it may be accomplished by immersing the entire flask in hot water. Alternatively, the wax can be peeled from the mold 30 without heating after the plaster 44 has hardened and the cope and drag have been separated.

When the wax 34 has been removed and the flask portions are separated, a molding resin 50 of the aforementioned variety is placed over the nose 30 as by squeezing it from a tube 52 and adding curing catalysts. The cope section 42 is then returned to position above the drag 38, as shown in FIG. 10, so that the pinlike extensions 48 from the upper layer of plaster 44 penetrate through the resin 50. The resin 50 is then cured by heating to about 700 F. for about 30 minutes if vinyl resin is used or by aging for about minutes after adding a curing catalyst if a silicone or acrylic is used. During aging and molding the flask 40 may be maintained between the upper and lower plates 58 and 60 of an appropriate press.

After the resin has been cured, the cope 42 is separated from the drag 38 and the finished protective device 10 is peeled from the lower mold of the nose 30. The thin, molded, shell-like protective device 10 as shown in FIG. 11 conforms to the features of the nose impression which was obtained as shown in FIG. 4. The device has a plurality of tiny throughpores 12 (some shown) which correspond to the pinlike extensions 48 from the cope portion of the flask.

As shown in FIG. 11, an adhesive 60 may be sprayed from an appropriate aerosol nozzle 61 evenly onto the entire inner surface of the device so that it can be retained in the position shown in FIG. 2 without danger of bumping or slipping out of place.

Alternatively, the through-pores 12 in the device may be formed by perforating the device with a stylus or pin after it is completely formed. In this case, the step of perforating the wax as shown in FIG. 7 is omitted. In some cases it is possible to eliminate the perforations l2 altogether byjust applying the adhesive to the upper inner surface of the device. It has been found that when this is done the lower portion of the device provides protection for the nose and remains in place because of its form fit, but is not so tight fitting that ventilation pores are necessary. Adequate ventilation is provided by the finite spacing between the skin tissue of the wearer and the inner surface of the device.

Rather than using the spray adhesive as shown in FIG. ll a double sided adhesive tape 64 can be used to form two strips along the inner surfaces of the device which adhesively maintain the device in position as shown in FIG. 12.

It has been found that an ejector-type flask commonly used by dental practitioners for forming dentures can be conveniently used in the process of this invention with the size molds needed.

The process of this invention can be simply incroporated into a mail order system for providing custom-shaped protective devices. For example the powdered algenate, the curved molding cup, and the finishing mold cup can be provided as a packet which are mailed to the potential user to obtain the impression. By providing a simple set of instructions the user can add water to the algenate to form the soft impressionable material which he then places over his nose as shown in FIG. 4

and removes after an impression has been obtained. The algenate impression can then be, returned so that the manufacturer can carry out the other steps of the process and form the protective device. It is also possible to provide small concerns with the necessary materials to obtain impressions and to custom mold the protective devices at their establishment.

Alternatively, measurements of the nose or other body portions of a wearer can be obtained and medium, large and small protective devices which best fit the measurements can be provided for the wearer. In this manner a standard series of sizes of the protective device can be marketed and purchased as needed by the wearers.

The invention may e embodied in other specific forms without departing from the spirit or essential characteristics thereof. The present embodiment is therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.

What I claim is:

l. A protective device for shielding exposed portions of the nose from the ultraviolet radiation from the sun comprising:

a reusable, soft, highly resilient; form-retaining, thin-walled elastomeric member molded in the shape of a nose for fitting over the exposed nose portion;

adhesive means on at least a portion of the inner surface for attaching said molded member to said exposed nose portion; and

means on said device for providing ventilation of said exposed nose portion without permitting the entry of substantial amounts of ultraviolet radiation through said device, said device being very readily attachable and detachable from said exposed nose portion.

2. A device as defined in claim 1 wherein said elastomeric member is a silicone resin.

3. A device as defined in claim 1 wherein said elastomeric member is an acrylic resin.

4. A device as defined in claim I wherein said elastomeric member is a vinyl resin.

5. A device as defined in claim 1 wherein said ventilation means comprise a plurality of minute pores extending through said molded member.

6. A device as defined in claim I wherein said adhesive layer is only applied to the upper inner surface of said molded member and said ventilation providing means comprise the finite spacing between the layer portion of said member and the skin tissue of the wearer.

7. A device as defined in claim 1 wherein said molded member has a durometer hardness of about 50 Shore A, a tensile strength of about 525 p.s.i., a tear strength of about 29 p.s.i. and an elongation of about 230 percent.

8. A device as defined in claim 1 wherein said attaching means comprise two-sided adhesive tape on the inner surfaces ofsaid device. 

1. A protective device for shielding exposed portions of the nose from the ultraviolet radiation from the sun comprising: a reusable, soft, highly resilient, form-retaining, thin-walled elastomeric member molded in the shape of a nose for fitting over the exposed nose portion; adhesive means on at least a portion of the inner surface for attaching said molded member to said exposed nose portion; and means on said device for providing ventilation of said exposed nose portion without permitting the entry of substantial amounts of ultraviolet radiation through said device, said device being very readily attachable and detachable from said exposed nose portion.
 2. A device as defined in claim 1 wherein said elastomeric member is a silicone resin.
 3. A device as defined in claim 1 wherein said elastomeric member is an acrylic resin.
 4. A device as defined in claim 1 Wherein said elastomeric member is a vinyl resin.
 5. A device as defined in claim 1 wherein said ventilation means comprise a plurality of minute pores extending through said molded member.
 6. A device as defined in claim 1 wherein said adhesive layer is only applied to the upper inner surface of said molded member and said ventilation providing means comprise the finite spacing between the layer portion of said member and the skin tissue of the wearer.
 7. A device as defined in claim 1 wherein said molded member has a durometer hardness of about 50 Shore ''''A,'''' a tensile strength of about 525 p.s.i., a tear strength of about 29 p.s.i. and an elongation of about 230 percent.
 8. A device as defined in claim 1 wherein said attaching means comprise two-sided adhesive tape on the inner surfaces of said device. 